Date

2025-01-22

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

Study Sites: • Sri Jayewardenepura General Hospital • National Hospital of Sri Lanka • National Hospital, Kandy • Kurunegala Teaching Hospital • Karapitiya Teaching Hospital Intervention: This trial will evaluate a total of 26 doses of 400mg sibeprenlimab (administered every 4 weeks). The IMP will be supplied as vials or prefilled syringes (PFS). The IMP will be administered SC once every 4 weeks by trained, qualified personnel designated by the investigator or sponsor. The SC injection site will be the abdomen, thigh, or upper arm per subject discretion. The date and time of IMP administration, the volume of IMP administered, and the injection site location will be recorded for each IMP administration. A total of 26 doses are planned to be administered, with Dose 1 administered on Day 1 and Dose 26 administered in Week 100.Subjects will complete a follow-up visit in Week 104. The end-of-trial visit will take place in Week 112, at which time final assessments will be performed. Subjects discontinuing treatment prior to Dose 26 will complete the early discontinuation visit where the assessments done at week 104 will be performed at the time of treatment discontinuation and will be encouraged to complete the remainder of all planned trial visits after treatment discontinuation.

Next Version

Study Sites • Sri Jayewardenepura General Hospital • National Hospital of Sri Lanka • National Hospital, Kandy • Kurunegala Teaching Hospital